MHRA-100024-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • LAROTRECTINIB
Invented Name
VITRAKVI
PIP Number MHRA-100024-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
Route(s) of administration
  • Oral use
  • Gastric use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LAROTRECTINIB.pdf
Published Date 17/05/2022